DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is described as a precautionary measure due to potential contamination, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Unipharma, LLC is recalling 1,344 cartons of DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor. The affected product is identified by Lot 80054 and an expiration date of 10/31/20. The recall was initiated as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
The product was distributed nationwide and in Venezuela. Consumers should check their medicine cabinets for this specific lot and expiration date. If found, they should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — OTC Cough & Cold
- Hazard
- Affected units
- 1,344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 80054 Exp. 10/31/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Unipharma, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Unipharma, Llc.
See all →- ModerateDrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-10-16
- SevereDrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
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- ModerateCVS Children's Nasal Saline Drops Recalled for B. cepacia Contamination Risk
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- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
FDA (Drugs) · 2019-08-14
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Similar recalls
- ModerateDrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-10-16
- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
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- HighChildren's Cough Medicine Recalled for Manufacturing Control Deficiency
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FDA (Drugs) · 2019-08-14
- SevereDrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
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- SevereKingston Pharma Recalls Infant Cough Syrup Due to Microbial Contamination
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